Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy
研究概览
简要总结
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
详细描述
The Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed to compare the proposed biosimilar LA-EP2006 with the reference pegfilgrastim in woman with early stage breast cancer receiving (neo)-adjuvant myelosuppressive chemotherapy. Patient received TAC (intravenous docetaxel 75mg/m^2, doxorubicin 50 mg/m^2, and cyclophosphamide 500mg/m^2) on day1 of each cycle, for six or more cycles. A total of 308 patients were randomized to LA-EP2006 (n=155) or reference Neulasta® (n=153). Treatment was given subcutaneously on day 2 of each cycle. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count <0.5 × 10^9 cells/L). LA-EP2006 was equivalent to the reference product in DSN (difference: -0.16 days; 95% CI [-0.40, 0.08]). Further, LA-EP2006 and the reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically proven breast cancer
- •eligible for six cycles of neoadjuvant or adjuvant chemotherapy
排除标准
- •concurrent or prior chemotherapy for breast cancer
- •concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
- •concurrent prophylactic antibiotics
- •previous therapy with any G-CSF (granulocyte-colony stimulating factor) product
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
LA-EP2006
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
干预措施: LA-EP2006 (Drug)
Neulasta®
During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
干预措施: Neulasta® (Drug)
结局指标
主要结局
Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy
时间窗: 21 days (Cycle 1 of chemotherapy treatment)
Mean duration of severe neutropenia, defined as number of consecutive days with ANC \<0.5 × 10\^9/l (grade 4 neutropenia).
次要结局
- Incidence of Febrile Neutropenia (FN)(across all cycles (18 weeks))
- Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles(across al cycles (18 weeks))
- Mortality Due to Infection(Study course (19 weeks))
- Time to ANC Recovery in Days in Cycle 1(across Cycle 1 (3 weeks))
- Depth of ANC Nadir in Cycle 1(Cycle 1 (3 weeks))
- Number of Patients With ANC Nadir Per Day in Cycle 1(Cycle 1 (3 weeks))
- Frequency of Infections by Cycle and Across All Cycles(across all cycles (18 weeks))